Centre for Big Data Research in Health, Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia.
Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.
Br J Clin Pharmacol. 2021 Oct;87(10):3706-3720. doi: 10.1111/bcp.14798. Epub 2021 Mar 16.
Routinely collected data have been increasingly used to assess long-term opioid therapy (LTOT) patterns, with very little guidance on how to measure LTOT from these data sources. We conducted a systematic review of studies published between January 2000 and July 2019 to catalogue LTOT definitions, the rationale for definitions and LTOT rates in observational research using routinely collected data in nonsurgical settings. We screened 4056 abstracts, 210 full-text manuscripts and included 128 studies, mostly from the United States (81%) and published between 2015 and 2019 (69%). We identified 78 definitions of LTOT, commonly operationalised as 90 days of use within a year (23%). Studies often used multiple criteria to derive definitions (60%), mostly based on measures of duration, such as supply days/days of use (66%), episode length (21%) or prescription fills within specified time periods (12%). Definitions were based on previous publications (63%), clinical judgment (16%) or empirical data (3%); 10% of studies applied more than one definition. LTOT definition was not provided with enough details for replication in 14 studies and 38 studies did not specify the opioids evaluated. Rates of LTOT within study populations ranged from 0.2% to 57% according to study design and definition used. We observed a substantial rise in the last 5 years in studies evaluating LTOT with large variability in the definitions used and poor reporting of the rationale and implementation of definitions. This variation impacts on research reproducibility, comparability of findings and the development of strategies aiming to curb therapy that is not guideline-recommended.
常规收集的数据已越来越多地用于评估长期阿片类药物治疗（LTOT）模式，但对于如何从这些数据源中测量 LTOT，几乎没有指导。我们对 2000 年 1 月至 2019 年 7 月期间发表的研究进行了系统回顾，以编目非手术环境中使用常规收集数据的观察性研究中的 LTOT 定义、定义的基本原理和 LTOT 率。我们筛选了 4056 篇摘要、210 篇全文，并纳入了 128 项研究，这些研究主要来自美国（81%）和 2015 年至 2019 年期间发表的研究（69%）。我们确定了 78 种 LTOT 定义，通常将一年内使用 90 天定义为 LTOT（23%）。研究通常使用多种标准来推导定义（60%），主要基于持续时间的测量，例如供应天数/使用天数（66%）、疗程长度（21%）或特定时间段内的处方填充量（12%）。定义基于以前的出版物（63%）、临床判断（16%）或经验数据（3%）；10%的研究应用了多种定义。14 项研究没有提供足够的 LTOT 定义细节以供复制，38 项研究没有指定评估的阿片类药物。根据研究设计和使用的定义，研究人群中的 LTOT 率从 0.2%到 57%不等。我们观察到，在过去的 5 年中，评估 LTOT 的研究数量大幅增加，使用的定义差异很大，并且对定义的基本原理和实施情况的报告也很差。这种变化会影响研究的可重复性、研究结果的可比性以及旨在遏制不符合指南推荐的治疗的策略的制定。
